STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM

K020097 · Stryker Endoscopy · JDW · Mar 15, 2002 · Orthopedic

Device Facts

• Record ID: K020097
• Device Name: STRYKER INTERFERENCE SCREW CROSS PIN SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: JDW · Orthopedic
• Decision Date: Mar 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendon-tibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

Device Story

System provides interference fixation for ACL reconstruction; consists of interference screw with transverse hole and optional cross pin. Used in orthopedic surgery; implanted by surgeons. Drill guide ensures alignment for cross pin insertion. Provides mechanical fixation of grafts (patellar tendon, semitendinosus, semi-membranosus, Achilles) to bone. Enhances graft stability during healing.

Clinical Evidence

Bench testing only. Biocompatibility per ISO-10993 and G95-1. Sterility validated to SAL 10^-6 per EN 550/EN 552.

Technological Characteristics

Metallic bone fixation fastener; interference screw with transverse hole and optional cross pin. Materials biocompatible per ISO-10993. Sterilization via Gamma irradiation (EN 552) or Ethylene oxide (EN 550). Single-use. Packaging per ASTM 4169.

Indications for Use

Indicated for patients undergoing surgical reconstruction of an ACL-deficient knee requiring interference fixation of allografts or autografts.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker Wedge Interference Screw (K972233)

Submission Summary (Full Text)

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K02 0097

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### Device Name

Classification Name:

Common and Usual Name: Proprietary Name:

Smooth or Threaded Metallic Bone Fixation Fasteners: 21 CFR §888.3040, Class II Threaded Fixation Pin (87 JDW) Stryker Interference Screw Cross Pin System

#### Predicate Device

Stryker Wedge Interference Screw (#K972233) currently marketed by Stryker Endoscopy (Santa Clara, CA).

#### Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patellar tendon-tibial bone graft complex, the semitendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft. The interference screw fixation technique is a common method in orthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Journal of Arthroscopic and Related Surgery.

The Stryker Interference Screw Cross Pin System consists of an implant and associated instruments for installation of the implant . The implant consists of two components: an interference screw with cross pin hole, and a cross pin for the interference screw. The interference screw has a transverse hole in it for receipt of the cross pin. The cross pin is available for optional use by the user, in the event that adjunctive fixation is deemed appropriate. A drill guide provides alignment for drilling a hole coincident with the hole in interference screw and for receiving the cross pin.

Both implants will be provided sterile for single-use applications (ASTM 4169). These devices will be sterilized by Gamma irradiation (EN 552) or Ethylene oxide (EN550), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10 °. The devices are biocompatible per ISO-10993 and G95-1. The Stryker Interference Screw with Cross Pin is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The Stryker Interference Screw Cross Pin System is considered substantially equivalent to the Stryker Wedge Interference Screw System.

Contact:

Date: January 4, 2002

Alisa Miller Quality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 [phone] x.2259

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2002

Ms. Alisa Miller Ouality Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K020097

Trade Name: Stryker Interference Screw Cross Pin System Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Number: 888.3040 Regulatory Class: II Product Code: JDW Dated: January 4, 2002 Received: January 10, 2002

Dear Ms. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2 - Ms. Alisa Miller

This letter will allow you to begin marketing your device as described in your Section 510(k) rms seket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

R. Mark N. Miller

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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January 4, 2002

510(k) Number if known: K020097

### INDICATION FOR USE:

The Stryker Interference Screw Cross Pin System is intended for use in the surgical reconstruction of the anterior cruciate ligament (ACL) deficient knee to provide interference fixation of the various ACL allografts and autografts, including the patella bone-patellar tendontibial bone graft complex, the semi-tendinosus tendon graft, the semi-membranosus tendon graft, and the Achilles tendon graft.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) OR

Over-the-Counter Use

Mark N Millenn
(Division Sign-Off)

Division of G and resubrative and Neurological Devices

510(k) Number K020097

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